510(k) K220939

MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A by Siemens Medical Solutions USA, Inc. — Product Code LNH

K220939 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A". The FDA issued a decision of Substantially Equivalent on Apr 29, 2022. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 29, 2022
Date Received
Mar 31, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type
510(k)